Southern Oklahoma Surgical Center, Inc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/29/2021. The findings were reviewed with the histotechnician at the conclusion of the survey. The laboratory was found in compliance with a standard-level deficiency cited. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the histotechnician, the laboratory failed to document the reactivity of the H&E (Hematoxylin & Eosin) stain each day of testing for two of 34 days of patient testing. Findings include: (1) On 11/29/2021 at 11: 45 am, the histotechnician stated the laboratory performed microscopic interpretations of histology specimens that had been stained with H&E (Hematoxylin & Eosin) stain; (2) The surveyor reviewed test records for 34 days of patient testing (microscopic interpretations) performed from January 2020 through March 2020 and August 2021 through October 2021. There was no evidence that the reactivity of the stain had been observed for acceptability for two (03/06/2020 and 10/29/2021) of the 34 days; (3) The surveyor reviewed the findings with the histotechnician who stated on 11/29/2021 at 01:35 pm, the reactivity of the stain was observed for acceptability on each patient slide, but had not been documented as indicated above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 11/04/19. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the histotechnician at the conclusion of the survey. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a review of records, written policies, and interview with the histotechnician, the laboratory failed to have a written protocol that included the frequency of microscope maintenance. Findings include: (1) At the beginning of the survey, the histotechnician stated to the surveyor the laboratory prepared slides from frozen sections of dermatological biopsy specimens and from Mohs surgical specimens. The slides were then stained with H & E (Hematoxylin and Eosin), dried, coverslipped, and microscopically examined for diagnosis by the laboratory director using the Leica microscope; (2) The surveyor reviewed the laboratory's written procedure, "Equipment Quality Control-Microscope," which included the following: (a) Stage and ocular eyepieces to be cleaned as needed (b) The stage is to be cleaned with alcohol or similar cleaner (c) Ocular eyepieces are to be cleaned with lens paper (3) The surveyor identified the microscope maintenance protocol did not define the frequency the maintenance procedures listed above were to be performed; (4) The surveyor reviewed the findings with the histotechnician who stated to the surveyor the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- laboratory's written procedure did not include the frequency at which microscope maintenance procedures were to be performed. -- 2 of 2 --